| Class 2 Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire | |
Date Initiated by Firm | January 10, 2013 |
Date Posted | March 15, 2013 |
Recall Status1 |
Terminated 3 on July 18, 2013 |
Recall Number | Z-0952-2013 |
Recall Event ID |
64330 |
Product Classification |
Passer, wire, orthopedic - Product Code HXI
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Product | Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge. |
Code Information |
Catalog Number 101-00006; Lot Number 00921538. |
Recalling Firm/ Manufacturer |
Extremity Medical LLC 300 Interpace Pkwy Ste 410A Parsippany NJ 07054-1148
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For Additional Information Contact | Mr. Brian A. Smekal 973-588-8988 |
Manufacturer Reason for Recall | The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended. |
FDA Determined Cause 2 | Component change control |
Action | Extremity Medical sent an "URGENT: FIELD SAFETY NOTICE" dated January 10, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return. Contact Customer Service at 1 (973) 588-8980 for questions regarding this notice.
On April 10, 2013, Extremity sent notifications to their customers at the surgeon level. They were asked to complete the attached product field action response form. |
Quantity in Commerce | 238 units |
Distribution | Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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